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The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.

The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
MATERIALS: Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.

I am sorry, but the provided text is a 510(k) K233419 FDA clearance letter and related summary for a dental device called "GBR System". This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

It does not contain information about acceptance criteria for a study proving device performance, nor details about a study that would meet such criteria. Therefore, I cannot extract the requested information from this document.

The document discusses:

• Non-clinical tests: Biocompatibility, Insertion Torque, Fracture Torque, Pull-out tests, sterilization validation, and MRI compatibility. These are primarily engineering and material characterization tests, not clinical studies with acceptance criteria for device performance in patients.
• Comparison to predicate devices: This is done to establish substantial equivalence, not to prove that the device meets specific performance acceptance criteria from a clinical study.

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The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.

The GBR System is comprised of bone screws and bone plates that are used for bone fixation surgery. The bone screws and plates are not reusable. The bone screws are composed of the titanium alloy (ASTM F136) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (0.85, 1.4, 2.0 mm) and length (3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 mm). Also, the tip of screw has single type; the self-drilling and self-tapping available type and the type that require the pre-drilling (Surgeon's option). The bone plate is offered in 0.1 mm thickness and in length 22 mm x 15 mm, 36 mm x 22 mm and 44 mm x 44 mm. Each device is provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended.

The provided text describes a 510(k) premarket notification for the "GBR System" (K170697), a bone fixation system. The testing outlined assesses the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria for a new, standalone device's performance in a diagnostic or clinical efficacy context. Therefore, direct acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, AUC) and a study proving a device meets these in the way typically seen for AI/diagnostic devices are not applicable or present in this document.

However, I can extract the non-clinical performance testing conducted and its reported outcomes, which serve as the "acceptance criteria" for demonstrating substantial equivalence based on physical and biological properties.

Here's the information based on the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "bench testing" and "test results and analysis" but does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and not provided. The "acceptance criteria" here relate to physical, mechanical, and biological properties of the device, not a diagnostic or clinical performance where expert-established ground truth would be relevant.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As above, adjudication methods apply to expert-based ground truth establishment, which is not relevant to the non-clinical bench and biocompatibility testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not mentioned and is not applicable to this type of device (bone fixation system) or the non-clinical testing described. This device is a physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This device is a physical medical device, not an algorithm, and therefore "standalone" performance in this context is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance testing, the "ground truth" is defined by the standards and specifications outlined in the referenced ASTM and ISO standards. For example, for mechanical tests, the ground truth is the expected mechanical behavior according to the standard and comparison to the predicate device. For biocompatibility, it's compliance with ISO 10993 standards. For sterilization, it's achieving the specified SAL.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical medical device and does not involve AI/machine learning, so there is no training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As there is no training set for this type of device, this question is not relevant.

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Neo GBR System is intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.

The Neo GBR System is made of Titanium Alloy. This product is a sterilized single use medical device. This system consists of Tent screw and CTi Cover Screw. The function of the Tent Screw is temporarily Intraosseous Fixation Screw that places in the maxilla or mandible bone area to be combined with a titanium membrane of K 111761 and CT cover screw. Second surgery for removal is required. The product diameters are 2.0mm and the lengths are 7.2/8.7/10.2/11.7/13.2/15.2/18.2mm. The Tent Screw and CTi-Cover screw are always packaged together. But CTi-Cover Screw is packaged separately for the convenience. 4 pcs of Tent Screw can be packaged in a box as a bundle set.

The provided document does not describe a study that uses acceptance criteria to prove the device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for the "Neo GBR System," which is an implantable medical device (intraosseous fixation screw or wire).

The document details bench testing conducted for the Neo GBR System to confirm its physical properties, but this testing is not an AI/ML performance study as typically described with acceptance criteria like sensitivity, specificity, or AUC, nor does it involve human readers or ground truth derived from expert consensus, pathology, or outcomes data in the way an AI/ML study would.

Here's an analysis based on the information available, noting the absence of AI/ML specific information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "The testing results meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific quantitative acceptance criteria and the detailed performance results for each test (visual test, compressive loads, pull out, driving torque, and insertion-elimination tests) are not provided in this summary. It only states that they meet the requirements.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available in the provided summary. The document mentions "bench testing," which implies physical tests on the manufactured device, not a test set of data (images, clinical records, etc.) as would be used for an AI/ML algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is a physical fixation system, not an AI/ML algorithm requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable. The device is a physical implant, not an AI/ML system that enhances human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as it is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be the physical properties and mechanical thresholds established for the device's function (e.g., maximum compressive load before failure, torque required for insertion/removal). The biocompatibility tests also have established standards (ISO 10993-1). However, specific quantitative values are not provided in the summary.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

Summary of Non-Clinical Testing Performed (from the document):

• Tests: Visual test, compressive loads, pull out, driving torque, and insertion-elimination tests.
• Standards: Conducted in accordance with ASTM F543-13.
• Biocompatibility: Cytotoxicity, irritation, and sensitization tests in accordance with ISO 10993-1.
• Stability and Compatibility: Tests between the tent screw and CTi-cover screw to evaluate adaptation accuracy.

Conclusion from document: "The testing results meet the requirements of its pre-defined acceptance criteria and intended uses."

In essence, the provided document describes the regulatory submission for a physical medical device and does not contain the kind of AI/ML performance study information requested in the prompt.

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The GBR System is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

The GBR System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The GBR System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V). The device screw is available in three different types, Auto Screw, Tenting Screw and GBR Screw. The device plate is provided in two different types, mesh plate and GBR mesh plate. The device system also includes various manual surgical instruments, such as mesh puncher, screwdriver handle, screw block, driver shaft and drill bit. The GBR System is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The GBR System is provided as silver color which is casted according to the anodizing technique while apply 5 V ~ 10 V electric energy to the titanium.

The provided text describes a 510(k) summary for the "GBR System" medical device, which consists of bone plates and screws. The submission aims to demonstrate substantial equivalence to a predicate device, the "Jeil Bone Fixation System" (K050669).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum tensile strength), but rather implies that the device is acceptable if its performance is "equivalent" to the predicate device. The performance is assessed through non-clinical testing based on ASTM standards.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many screws were tested for driving torque). It states that the evaluation was based on ASTM F543-13. The data provenance is presumed to be from laboratory testing conducted by Jeil Medical Corporation. There is no mention of country of origin for the data or whether it was retrospective or prospective, as it's non-clinical lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The "ground truth" for the non-clinical tests is established by objective engineering measurements against ASTM standards, not by expert interpretation.

4. Adjudication method for the test set

This information is not applicable. Since the testing is non-clinical and objective, there is no need for adjudication by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. This device is a physical medical implant (bone plates and screws) and not an AI-assisted diagnostic tool or software, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The GBR System is a physical medical device, not an algorithm or software. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the objective measurements against the established ASTM standards for mechanical properties (driving torque, axial pull-out, torsion, tensile strength). For material, it's compliance with ASTM F67 and ASTM F136 specifications.

8. The sample size for the training set

This information is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning model. There is no "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

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The Straumann GBR System is intended for use in stabilizing and fixating bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. The GBR technique can make it possible for the placement of dental implants in previously unsuitable sites.

The Straumann GBR System is comprised of bone plates, meshes, screws, and accompanying instruments. The cranial plates are offered in 2, 4, and 6 hole options. Screws with diameters of 1.2 and 1.5mm are used to secure the cranial plates in place. The plates and screws are composed of commercially pure Grade 4 titanium meeting ASTM F67.

The 0.9 and 1.5 mesh are available in uniform mesh size and pattern, and alternating mesh size and patterns. Screws with diameters of 1.2 and 1.5mm are used to secure the mesh in place. The meshes are composed of commercially pure Grade 1 titanium meeting ASTM F67.

The Straumann GBR System also includes a fixation screw used to stabilize and adapt the membranes. There are two variations of supporting screws which prevent the membrane from collapsing into the defect site, and in conjunction with a head screw, provide membrane fixation and support. The screws are composed of stainless steel.

The provided text is a 510(k) summary for the Straumann GBR System, which includes regulatory information, device description, and an intended use statement. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details typically found in a clinical study report.

Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission for substantial equivalence to predicate devices, focusing on materials and intended use rather than detailed performance evaluations with specific metrics.

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